中国组织工程研究 ›› 2025, Vol. 29 ›› Issue (29): 6305-6316.doi: 10.12307/2025.763

• 组织构建循证医学 evidence-based medicine in tissue construction • 上一篇    下一篇

针灸治疗绝经后骨质疏松症的Meta分析、系统评价和试验序贯分析

虞兵兵1,2,王婷婷3,方俊霖1,2,郭  云2,黄英如1   

  1. 重庆医科大学,1中医药学院,3护理学院,重庆市  400016;2重庆医科大学附属铜梁区中医院骨伤科,重庆市  402560

  • 收稿日期:2024-08-19 接受日期:2024-10-08 出版日期:2025-10-18 发布日期:2025-03-08
  • 通讯作者: 黄英如,博士,教授,博士生导师,重庆医科大学中医药学院,重庆市 400016
  • 作者简介:虞兵兵,男,1997年生,重庆医科大学在读硕士,主要从事手法复位、微创技术治疗骨折、脱位、软组织损伤等研究。
  • 基金资助:
    国家自然科学基金面上项目(81674002),项目负责人:黄英如;国家中医药管理局全国基层名老中医传承工作室建设项目(国中医药人教发[2018]133号),项目参与人:郭云;重庆市科卫联合中医药科研项目(2023MSXM184),项目参与人:郭云;第四批全国中医(临床、基础)优秀人才研修项目(国中医药人教发[2017]24号),项目负责人:郭云

Acupuncture for treatment of postmenopausal osteoporosis: meta-analysis, systematic evaluation and trial sequential analysis

Yu Bingbing1, 2, Wang Tingting3, Fang Junlin1, 2, Guo Yun2, Huang Yingru1   

  1. 1School of Traditional Chinese Medicine, Chongqing Medical University, Chongqing 400016, China; 2Department of Orthopedics, Tongliang District Hospital of Traditional Chinese Medicine Affiliated to Chongqing Medical University, Chongqing 402560, China; 3School of Nursing, Chongqing Medical University, Chongqing 400016, China
  • Received:2024-08-19 Accepted:2024-10-08 Online:2025-10-18 Published:2025-03-08
  • Contact: Huang Yingru, MD, Professor, Doctoral supervisor, School of Traditional Chinese Medicine, Chongqing Medical University, Chongqing 400016, China
  • About author:Yu Bingbing, Master’s candidate, School of Traditional Chinese Medicine, Chongqing Medical University, Chongqing 400016, China; Department of Orthopedics, Tongliang District Hospital of Traditional Chinese Medicine Affiliated to Chongqing Medical University, Chongqing 402560, China
  • Supported by:
    National Natural Science Foundation of China (General Program), No. 81674002 (to HYR); National Grassroots Famous Traditional Chinese Medicine Inheritance Studio Construction Project of the National Administration of Traditional Chinese Medicine, No. [2018]133 (to GY [project participant]); Chongqing Science and Health Joint Traditional Chinese Medicine Research Project, No. 2023MSXM184 (to GY [project participant]); The Fourth Batch of National Traditional Chinese Medicine (Clinical, Basic) Excellent Talent Training Project, No. [2017]24 (to GY)

摘要:


文题释义:
针灸疗法:是一种传统中医疗法,通过在特定腧穴或经络施以针法或灸法,以调节身体的气血运行,达到治疗疾病、缓解症状的目的。针灸疗法历史悠久,应用广泛,已经逐渐成为临床治疗绝经后骨质疏松症等骨代谢类疾病的一种重要替代治疗方案。目前针灸疗法主要包括毫针针刺、电针、温针、艾灸、督灸等。
骨质疏松症:是一种以骨密度降低和骨脆性增加为特征的骨骼系统疾病,可大幅度增加骨折风险。骨质疏松症分为原发性骨质疏松症和继发性骨质疏松症,其中原发性骨质疏松症较为常见。原发性骨质疏松症分为绝经后骨质疏松症、老年性骨质疏松症和特发性骨质疏松症。

目的:评估针灸治疗绝经后骨质疏松症的有效性和安全性。
方法:从中国知网、维普资讯中文期刊服务平台、万方数据知识服务平台、中国生物医学文献服务系统、Web of Science、PubMed、Embase以及Cochrane Library等数据库检索针灸治疗绝经后骨质疏松症的临床随机对照试验。检索时间为各数据库建库起至2024-07-23。使用GRADEprofiler和Cochrane随机对照试验偏倚风险评估工具2.0版对纳入研究的证据质量和偏倚风险进行评估。利用StataSE 15和TSA 0.9.5进行Meta分析、异质性分析、敏感性分析、亚组分析、发表偏倚分析、剪补法分析和试验序贯分析。
结果:纳入19项随机对照试验,共涉及1 464例患者。①通过Meta分析发现,与常规疗法相比,针灸疗法可显著提升总有效率[RR=1.25,95%CI(1.19,1.32),P < 0.001]、腰椎L2-L4骨密度[MD=0.08,95%CI(0.05,0.11),P < 0.001]、雌激素水平[SMD=0.55,95%CI(0.30,0.81),P < 0.001],也可提高股骨颈、股骨大转子、ward三角等部位骨密度和促性腺激素水平,降低目测类比评分以及改善骨代谢,且不良事件发生率未显著提高;②主要结局指标的亚组分析显示当体质量指数> 23.9 kg/m²、总疗程为6个月时,治疗组与对照组无显著性差异,其余亚组均显示治疗组显著优于对照组;③发表偏倚分析显示总有效率方面存在潜在发表偏倚风险,但通过剪补法分析显示该风险对结论的可靠性没有显著影响,而腰椎L2-L4的骨密度值和雌二醇水平方面不存在显著发表偏倚;④试验序贯分析进一步验证了针灸疗法可显著提高总有效率、腰椎L2-L4的骨密度值和雌二醇水平的确凿性。
结论:针灸疗法是治疗绝经后骨质疏松症一种有效、安全的疗法。未来需更多设计严谨、高质量的研究验证该结论。
https://orcid.org/0009-0000-5408-2513(虞兵兵)

中国组织工程研究杂志出版内容重点:组织构建;骨细胞;软骨细胞;细胞培养;成纤维细胞;血管内皮细胞;骨质疏松;组织工程

关键词: 针灸, 绝经后骨质疏松症, 雌激素, 随机对照试验, Meta分析, 试验序贯分析, 系统评价

Abstract: OBJECTIVE: To assess the efficacy and safety of acupuncture in treating postmenopausal osteoporosis.
METHODS: Clinical randomized controlled trials on acupuncture for postmenopausal osteoporosis were retrieved from databases including CNKI, VIP, WanFang, China Biomedical Literature Service System, Web of Science, PubMed, Embase, and Cochrane Library. The search period was from the inception of the database to July 23, 2024. The quality of evidence and risk of bias of the included studies were assessed using the GRADEprofiler and the revised Cochrane risk-of-bias tool for randomized trials (RoB 2.0). Meta-analysis was performed using StataSE 15 and TSA 0.9.5, along with heterogeneity analysis, sensitivity analysis, subgroup analysis, publication bias analysis, trim-and-fill analysis, and trial sequential analysis. 
RESULTS: The study included 19 randomized controlled trials involving a total of 1 464 patients. (1) The meta-analysis revealed that compared with conventional therapies, acupuncture significantly increased the total effective rate (RR=1.25, 95% confidence interval [1.19, 1.32], P < 0.001), lumbar spine 
L2-L4 bone mineral density (mean difference=0.08, 95% confidence interval [0.05, 0.11], P < 0.001), and estrogen levels (standard mean difference=0.55, 95% confidence interval [0.30, 0.81], P < 0.001). Additionally, acupuncture increased bone mineral density and gonadotropin levels in the femoral neck, greater trochanter, and Ward’s triangle, reduced visual analogue scale scores, and improved bone metabolism without significantly increasing the incidence of adverse events. (2) Subgroup analysis of the main outcome indicators showed no significant difference between the treatment and control groups when the body mass index was greater than 23.9 kg/m² and the total treatment duration was 6 months. All other treatment subgroups were significantly superior to the control group. (3) Publication bias analysis indicated a significant risk of publication bias in the overall efficacy; however, a trim-and-fill analysis showed that this risk did not significantly impact the reliability of the conclusions. Publication bias analysis showed no significant risk of publication bias in the bone mineral density values of lumbar spine L2-L4 and estradiol levels. (4) The sequential analysis of the trial further confirmed that acupuncture significantly increased the overall effective rate, bone mineral density values at the lumbar spine L1-L4, and estradiol levels. 
CONCLUSION: Acupuncture is an effective and safe treatment for postmenopausal osteoporosis. More rigorously designed and high-quality studies are needed in the future to verify this conclusion.

Key words: acupuncture, postmenopausal osteoporosis, estrogen, randomized controlled trials, meta-analysis, trial sequential analysis, systematic review

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